Venissieux

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are evaluating how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes T2D, lose weight. The purpose of this clinical study is to find out how safe and effective CagriSema is for body weight loss compared to semaglutide, a medicine already prescribed by doctors. This is a Phase 3 randomized trial lasting about 83 weeks. Participants will be randomly assigned to receive either one of two doses of CagriSema or semaglutide, all given once weekly by injection under the skin during a 72-week treatment period. CagriSema is a new medicine being tested, while semaglutide serves as an active comparator. The study compares these treatments for their effects on weight loss and related health measures. During the study, participants will have regular assessments including body weight, body mass index BMI, waist circumference, cholesterol levels, and blood sugar control measured by HbA1c. Researchers will also monitor physical function and quality of life through questionnaires. Safety is tracked by recording any adverse events up to 80 weeks. The main outcome is the change in body weight from the start of treatment to the end of the 72-week period.

Researchers are evaluating the efficacy and safety of two different dose regimens of pegozafermin compared to a placebo in adults with Metabolic Dysfunction-Associated Steatohepatitis MASH and liver fibrosis at stages F2 or F3. This Phase 3 study aims to better understand how pegozafermin may help treat liver fibrosis in this population. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections according to one of two dosing regimens. The treatments are administered in a randomized, quadruple-masked design to ensure unbiased results. The study evaluates effects after 52 weeks of treatment and monitors participants for up to 5 years to assess disease progression. During the study, participants will undergo liver biopsies to confirm fibrosis stage and will have blood tests to measure liver enzymes and fibrosis markers. Researchers will track improvements in fibrosis, resolution of steatohepatitis, changes in liver enzyme levels, and liver fibrosis scores. Participants health and safety will be monitored throughout the study period, which includes follow-up assessments extending up to 5 years.

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This phase 3 study focuses on participants with biopsy-confirmed advanced fibrosis stage F4 MASH and aims to assess important clinical outcomes related to liver disease progression. Participants will be randomly assigned to receive either pegozafermin or a matched placebo, both given by subcutaneous injection. The study includes a double-blind design where neither the participants nor the researchers know who receives the active drug or placebo. The treatment period extends up to 24 months with follow-up for clinical events up to 5 years, allowing long-term monitoring of disease progression and fibrosis regression. Throughout the study, participants will undergo regular assessments including liver fibrosis measurements, liver enzyme tests, and elastography scans. Researchers will monitor the proportion of participants achieving fibrosis regression and track time to clinical disease progression. Additional evaluations include changes in liver fibrosis scores and development of portal hypertension, with safety assessments continuing up to 60 months. The total participation may last several years to capture these important outcomes.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating people with excess body weight. This Phase 3 clinical trial compares the medicine with a placebo, both given as weekly injections under the skin. The study focuses on how these treatments affect weight loss and other health measures related to obesity. Participants will be randomly assigned to receive one of four dose levels of NNC0487-0111 or a matching placebo. Both treatments are given once a week using a pre-filled pen injector applied to the thigh, abdomen, or upper arm. The treatment is combined with a reduced-calorie diet and increased physical activity. The study includes an initial treatment period lasting 84 weeks, with follow-up assessments continuing to week 136 and safety monitoring through week 140. During the study, participants will undergo regular evaluations including body weight, waist circumference, blood pressure, blood sugar levels, cholesterol, and quality of life surveys. Researchers will track adverse events and treatment effects at multiple time points from the start up to week 140. Participants will be closely monitored for safety throughout the trial, which runs from the baseline visit through extended follow-up periods.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.